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Cefuroxime Axetil + Clavulanic Acid

Generic Medicine
Indications

This combination is used for the treatment of infections caused by susceptible bacteria:

  • Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
  • Acute bacterial otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (including beta-lactamase producing strains) or Streptococcus pyogenes.
  • Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains).
  • Lower respiratory tract infections including pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus pyogenes and E. coli.
  • Acute bacterial exacerbation of chronic bronchitis and secondary bacterial infections of acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
  • Uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
  • Uncomplicated urinary tract infections caused by E. coli or Klebsiella pneumoniae.
  • Bone and joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains).
  • Uncomplicated gonorrhea caused by penicillinase and non-penicillinase producing strains of Neisseria gonorrhoeae.
  • Early Lyme disease (erythema migrans) caused by Borrelia burgdorferi.
  • Septicemia caused by Staphylococcus aureus, Streptococcus pneumoniae, E. coli, Haemophilus influenzae (including ampicillin-resistant strains) and Klebsiella spp.
  • Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis and Staphylococcus aureus (penicillinase and non-penicillinase producing strains).
  • Switch therapy (injectable to oral).
Pharmacology

Cefuroxime is a bactericidal second-generation cephalosporin antibiotic that is active against a broad range of Gram-positive and Gram-negative bacteria, including many beta-lactamase producing strains. It inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.

Clavulanic acid is a naturally derived beta-lactamase inhibitor produced by Streptomyces clavuligerus. It has a structure similar to beta-lactam antibiotics and binds irreversibly to beta-lactamase enzymes, thereby inactivating them. This protects Cefuroxime from degradation and enhances its activity against beta-lactamase producing resistant bacteria.

Dosage Administration

Adolescents and adults (13 years and older)-

  • Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
  • Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
  • Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
  • Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
  • Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
  • Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
  • Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
  • Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
  • MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
  • Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

  • Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
  • Acute otitis media: 30 mg/kg/day b.i.d for 10 days
  • Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
  • Impetigo: 30 mg/kg/day b.i.d for 10 days

Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.

Interactions

Co-administration of probenecid with Cefuroxime–Clavulanic Acid increases the serum concentration (AUC) of Cefuroxime by approximately 50%. Medications that reduce gastric acidity may decrease the bioavailability of Cefuroxime and can diminish its post-meal absorption effect.

Contraindications

Cefuroxime–Clavulanic Acid should not be used in patients with known hypersensitivity to cephalosporins or in those with pseudomembranous colitis.

Side Effects

Cefuroxime–Clavulanic Acid is generally well tolerated. However, some adverse effects such as nausea, vomiting, diarrhea, abdominal discomfort, or pain may occur. As with other broad-spectrum antibiotics, prolonged use may lead to the overgrowth of non-susceptible organisms. Rarely (<0.2%), renal dysfunction, anaphylaxis, angioedema, pruritus, rash, and serum sickness-like reactions such as urticaria may be observed.

Pregnancy & Lactation

All antibiotics should preferably be avoided during the first trimester of pregnancy. However, Cefuroxime–Clavulanic Acid may be used safely in later stages of pregnancy when necessary to treat infections. It is excreted in small amounts in breast milk; therefore, the possibility of sensitization in the infant should be considered.

Precautions & Warnings

Cefuroxime should be administered with caution in patients receiving potent diuretics and in those with a history of colitis.

Storage Conditions

Store in a cool, dry place below 30°C, protected from light and moisture. Keep out of reach of children.

Common Questions

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